On 20 October 2025, Teva announced that it has entered into a licensing agreement with Prestige Biopharma for the commercialisation of Tuznue®, biosimilar to Roche’s Herceptin® (trastuzumab), across a majority of European markets.
Under the agreement, Teva will market and distribute Tuznue® in a majority of European markets, while Prestige Biopharma will be responsible for production and supply through its EU-GMP-certified, high-tech facilities equipped with advanced single-use technology. Tuznue® was approved by the European Medicines Agency in September 2024, following the adoption of a positive opinion in July 2024.
Samsung Bioepis’ Ontruzant® was the first trastuzumab biosimilar to be approved in the EU (November 2017), followed by Celltrion’s Herzuma® (February 2018), Amgen’s Kanjinti® (May 2018), Pfizer’s Trazimera® (July 2018), Biocon’s Ogivri® (December 2018), Henlius/Accord’s Zercepec® (July 2020), and Sandoz’s Herwenda® (November 2023).